Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease
MUMBAI, India& PRINCETON, N.J.--(BUSINESS WIRE)-- August 16, 2018 -- Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715, “Sun Pharma” and includes its subsidiaries and/or associate companies)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Woodcliff Lake, NJ and Kenilworth, NJ, Aug. 16, 2018 – Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor Lenvima... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to & lt;24 Months with Certain Mutations in the CFTR Gene
BOSTON--(BUSINESS WIRE)--Aug. 15, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease
August 10, 2018 -- The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Annovera (segesterone acetate and ethinyl estradiol) Vaginal Contraceptive System
NEW YORK, Aug. 10, 2018 /PRNewswire/ -- The Population Council, a global nonprofit research organization, announced it has received U.S. Food and Drug Administration (FDA) approval for Annovera ™ (segesterone acetate and ethinyl estradiol vaginal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Onpattro (patisiran) Targeted RNA-based Therapy for Polyneuropathy Caused by hATTR
August 10, 2018 -- The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)
GEORGE TOWN, Cayman Islands--(BUSINESS WIRE)August 09, 2018 --Ironshore Pharmaceuticals& Development, Inc. ( “Ironshore”) a wholly owned subsidiary of Highland Therapeutics Inc. (“Highland”) announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria
WASHINGTON, Aug. 9, 2018 /PRNewswire/ -- 60 Degrees Pharmaceuticals (60P) announced today the U.S. Food and Drug Administration (FDA) approval of Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Poteligeo (mogamulizumab-kpkc) for Mycosis Fungoides and S ézary Syndrome
August 8, 2018 -- The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S ézary syndrome (SS) after... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years
BOSTON--(BUSINESS WIRE)--Aug. 7, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved Orkambi (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 7, 2018 Category: Drugs & Pharmacology Source Type: news

Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
JERUSALEM--(BUSINESS WIRE)--Aug. 6, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved Granix (tbo-filgrastim) Injection for a new vial presentation and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mulpleta (lusutrombopag) for Thrombocytopenia in Adults with Chronic Liver Disease
On July 31, 2018, the Food and Drug Administration approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Approval was based on two... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 31, 2018 Category: Drugs & Pharmacology Source Type: news

United Therapeutics Announces FDA Approval of the Implantable System for Remodulin
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., July 31, 2018 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for the use of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 31, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Azedra (iobenguane I 131) for Rare Adrenal Tumors
July 30, 2018 -- The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 30, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Perseris (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults
SLOUGH, England and RICHMOND, Va., July 27, 2018 /PRNewswire/ -- Indivior PLC (LON: INDV) today announced that the U.S. Food and Drug Administration (FDA) has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
NORTH CHICAGO, Ill., July 24, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 24, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria
London UK; Philadelphia US; Geneva, Switzerland - July 20, 2018 -- GSK and Medicines for Malaria Venture (MMV) today announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
July 20, 2018 -- The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2018 Category: Drugs & Pharmacology Source Type: news

Kisqali (ribociclib) Approved for Additional Indications in HR+/HER2- Advanced Breast Cancer
Basel, July 18, 2018 - Novartis today announced a new approval for Kisqali (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 18, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
TITUSVILLE, N.J, JULY 17, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson today announced the U.S. Food and Drug Administration (FDA) has approved Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide -... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves TPOXX (tecovirimat) as the First Drug for the Treatment of Smallpox
July 13, 2018 -- The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
TOKYO and NEW YORK, July 13, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 13, 2018 Category: Drugs & Pharmacology Source Type: news

Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer
PRINCETON, N.J.-- July 11, 2018 (BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xeomin (incobotulinumtoxinA) for Adult Patients with Sialorrhea (Excessive Drooling)
RALEIGH, N.C., July 3, 2018 -- Merz North America announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of chronic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 3, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Aristada Initio (aripiprazole lauroxil) for the Initiation of Aristada for Schizophrenia
DUBLIN, July 2, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Aristada Initio (aripiprazole lauroxil) for the initiation of Aristada (aripiprazole lauroxil), a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 2, 2018 Category: Drugs & Pharmacology Source Type: news

Dermira Receives FDA Approval for Qbrexza (glycopyrronium) Cloth to Treat Excessive Underarm Sweating
MENLO PARK, Calif., June 29, 2018 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 29, 2018 Category: Drugs & Pharmacology Source Type: news

Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)
SAN DIEGO--(BUSINESS WIRE)--Jun. 29, 2018-- Acadia Pharmaceuticals Inc. today announced FDA approval of a new capsule dose formulation and a new tablet strength of Nuplazid (pimavanserin) to help in the treatment of patients living with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mektovi (binimetinib) and Braftovi (encorafenib) in Combination for Unresectable or Metastatic Melanoma with BRAF Mutations
On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 27, 2018 Category: Drugs & Pharmacology Source Type: news

Array BioPharma Announces FDA Approval of Braftovi (encorafenib) in Combination with Mektovi (binimetinib) for Unresectable or Metastatic Melanoma with BRAF Mutations
BOULDER, Colo., June 27, 2018 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi capsules in combination with Mektovi tablets for the treatment of patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 27, 2018 Category: Drugs & Pharmacology Source Type: news

Zemdri (plazomicin) Approved by FDA for the Treatment of Adults with Complicated Urinary Tract Infections (cUTI)
SOUTH SAN FRANCISCO, Calif., June 26, 2018 (GLOBE NEWSWIRE) -- Achaogen, Inc., a biopharmaceutical company developing and commercializing innovative antibacterial agents to address multidrug resistant (MDR) gram-negative infections, today announced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 25, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Epidiolex (cannabidiol) to Treat Lennox-Gastaut Syndrome and Dravet Syndrome
June 25, 2018 -- The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 25, 2018 Category: Drugs & Pharmacology Source Type: news

Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
Parsippany, NJ – June 21, 2018 – The U.S. Food and Drug Administration (FDA) granted Ferring Pharmaceuticals Inc. approval to market Nocdurna, the first sublingual tablet for the treatment of nocturia due to nocturnal polyuria in adults who... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2018 Category: Drugs & Pharmacology Source Type: news

Shire Announces FDA Approval for Label Expansion of Cinryze (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients
Dublin, Ireland – Thursday, June 21, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Moxidectin for the Treatment of River Blindness
MELBOURNE, GENEVA, and NEW YORK - June 13, 2018 -- Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery
South San Francisco, CA -- June 13, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin ® (bevacizumab) in combination with chemotherapy... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
KENILWORTH, N.J.--(BUSINESS WIRE) June 13, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, the company ’s anti-PD-1 therapy, for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1
KENILWORTH, N.J.--(BUSINESS WIRE) June 12, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, the company ’s anti-PD-1 therapy, for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 12, 2018 Category: Drugs & Pharmacology Source Type: news

Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia
South San Francisco, CA -- June 8, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Rituxan ... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Rituxan (rituximab) for Pemphigus Vulgaris
South San Francisco, CA -- June 7, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) for the treatment of adults with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
On June 7, 2018, the Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 4, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Olumiant (baricitinib) 2 mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis
INDIANAPOLIS, June 1, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of Olumiant (baricitinib), a once-daily... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Consensi (amlodipine and celecoxib) for Treatment of Hypertension and Osteoarthritis Pain
TEL AVIV, Israel, May 31, 2018 (GLOBE NEWSWIRE) -- Kitov Pharma Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

TherapeuticsMD Announces FDA Approval of Imvexxy (estradiol vaginal inserts) for the Treatment of Dyspareunia Due to Menopause
BOCA RATON, Fla., May 30, 2018 /PRNewswire/ -- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Imvexxy (estradiol vaginal inserts)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis
Wednesday, May 30, 2018 - Pfizer Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 30, 2018 Category: Drugs & Pharmacology Source Type: news

UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis
Brussels, Belgium – 28th May, 07:00 CEST – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for Cimzia (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Palynziq (pegvaliase-pqpz) for the Treatment of Adults with Phenylketonuria
May 24, 2018 - The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 24, 2018 Category: Drugs & Pharmacology Source Type: news

GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age
London, UK 21 May 2018 --GSK today announced it has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) medicine for the maintenance... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 24, 2018 Category: Drugs & Pharmacology Source Type: news

Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer
MUMBAI& PRINCETON, N.J.& KING OF PRUSSIA, Pa. May 23, 2018 --(BUSINESS WIRE)--Sun Pharmaceutical Industries Ltd. and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) today announced that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 23, 2018 Category: Drugs & Pharmacology Source Type: news